Recruiting
Phase 2

Combination Immunotherapy

Sponsor:

University of Louisville

Code:

NCT03842943

Conditions

Cutaneous Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab

Talimogene Laherparepvec

Study Details

Brief summary:

Determine safety and efficacy of pre-operative combination immunotherapy with Talimogene Laherparepvec (T-VEC)/Pembrolizumab given prior to complete lymph node dissection in resectable stage 3 cutaneous melanoma with clinically apparent lymph node metastases.

Conditions

Cutaneous Melanoma

Study ID

NCT03842943

Start date

Jul 3, 2019

Status verified date

Apr, 2024

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years of age, any race or sex, who have pathologically confirmed cutaneous melanoma
  • ECOG performance status of 0 or 1
  • Adequate hematologic, hepatic, renal and coagulation function
  • Must have measurable disease and have an injectable target lymph node for intralesional therapy administration
  • Primary melanoma has been resected
  • Pathologically confirmed resectable stage III disease, clinically apparent. Resectability is at the discretion of the treating surgeon who is a melanoma specialist.
  • Stage III disease can be at time of diagnosis of primary melanoma or a recurrence after initial treatment of stage I-II disease.
  • BRAF mutant or wild type allowed (mutations status not necessary for enrollment)
  • Signed, written informed consent

Exclusion Criteria:

  • Cannot have metastatic (AJCC M1) disease
  • No primary mucosal or uveal melanoma
  • No evidence of melanoma associated with immunodeficiency state or history or other malignancies (other than non-melanoma skin cancer) within the past 3 years
  • May not have been previously treated with T-VEC, any other oncolytic virus, pembrolizumab, or any other PD-1, PD-L1, or PD-L2 inhibitor
  • Must not have a history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, document history of autoimmune disease or syndrome requiring systemic treatment in the past two years (i.e. use of disease modifying agents, steroids, or immunosuppressive agents) except vitiligo or resolved childhood asthma/atopy, or evidence of clinically significant immunosuppression
  • Must not have active herpetic skin lesions or prior complications of herpetic infection and must not require intermittent or chronic treatment with an anti-herpetic drug (e.g. acyclovir) other than intermittent topical use

Study Design

Enrollment

28 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Combination T-VEC/Pembrolizumab

Pre-operative talimogene laherparepvec (T-VEC) with Pembrolizumab

T-VEC - intra-lesional injection into palpable lymph nodes every 3 weeks for 6 months, or until complete response of target tumors.

Pembrolizumab - administered intravenously every 3 weeks for 6 months, then every 3 weeks for one year in the adjuvant setting following complete lymph node dissection.

Interventions

Pembrolizumab

Preoperative infusions

Talimogene Laherparepvec

Preoperative intralesional injection

Primary outcome measure

  • Pathologic Complete Response [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Michael Egger, MD

502-629-6950michael.egger@louisville.edu

Locations

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Stacy Baum

502-562-4370mary.baum@louisville.edu

More Information

Sponsor

University of Louisville

Last update posted

May 2, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2024-05-02.